Oral Health in Bariatric Patients

• Sponsor: University of Göttingen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03516201
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 82.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

As few is known about the oral health of bariatric patients, this study aimed to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.

Condition or Disease	Intervention/Treatment	Phase
Adiposity; Dental Diseases; Bariatric Surgery Candidate

Detailed Description

The prevalence of overweight and obesity is increasing since the 1980s. Being associated with several risk factors such as hypertension, hyperinsulinemia and hyperlipidemia, obesity presents an immediate and long-term health risk for diabetes mellitus, heart diseases, osteoarthritis and certain forms of cancer. For the control of obesity several therapy options have been developed: Beside conservative treatments including change of diet and lifestyle, bariatric surgery is considered as a promising option for patients with severe obesity (BMI ≥ 40 kg/m2). Allowing impressive weight loss from 40 to 80% and effective reduction of comorbidities, bariatric surgery shows some negative/adverse effects as well, like kidney problems, hyperparathyroidism, anemia and metabolic bone diseases. For oral health, two facts are particularly important to consider: Firstly, chronic regurgitation reaching the oral cavity is an important risk factor for erosive tooth wear which initially appear as smooth silky-shining glazed surfaces. Further progress is often associated with hypersensitivities and aesthetic deficits. Over time, often substantial loss can been observed, provoking hypersensitivities and aesthetic deficits. Secondly, depending on the type of bariatric surgery, pronounced postoperative metabolic and nutritional changes can be observed which also might influence oral health. Aim of this study is to analyze the prevalence and severity of erosive tooth wear, dental caries and periodontal diseases of obese patients who underwent bariatric surgery in comparison to obese patients without bariatric procedures.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Oral Health in Bariatric Patients
• Actual Study Start Date: Jun 15, 2018
• Actual Primary Completion Date: Feb 12, 2020
• Anticipated Study Completion Date: May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
obese patients after bariatric surgery obese adults (≥ 18 years) who underwent bariatric surgery
obese adultes without bariatric surgery obese adults (≥ 18 years) who did not underwent bariatric surgery at the time of the examination

Outcome Measures

Primary Outcome Measures

1. Oral health of obese adults without bariatric surgery - attachment loss [10-15 Minutes]

   probing depths (mm) + recessions (mm)

2. Oral health of obese adults without bariatric surgery - BOP [2 Minutes]

   BOP (Bleeding on probing, %) as indicator of inflammation

3. Oral health of obese adults without bariatric surgery - dental caries [2-5 Minutes]

   ICDAS (International Caries Detection and Assessment System II, 0-6), presence of restaurations/ crowns (yes/no): calculation of DMFT

4. Oral health of obese adults without bariatric surgery - erosive tooth wear [1-2 Minutes]

   BEWE (Basic erosive wear examination, 0-3)

Secondary Outcome Measures

1. Oral health of obese adults after bariatric surgery - attachment loss [10-15 Min]

   probing depths (mm) + recessions (mm)

2. Oral health of obese adults after bariatric surgery - BOP [2 Minutes]

   BOP (Bleeding on probing, %) as indicator of inflammation

3. Oral health of obese adults after bariatric surgery - dental caries [2-5 Minutes]

   ICDAS (International Caries Detection and Assessment System II, 0-6), presence of restaurations/ crowns (yes/no): calculation of DMFT

4. Oral health of obese adults after bariatric surgery - erosive tooth wear [1-2 Minutes]

   BEWE (Basic erosive wear examination, 0-3)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age ≥ 18 years

• BMI ≥ 25 kg/m2 without or after bariatric surgery

Exclusion Criteria:

• refusal for participation

• age <18 years

• BMI <25 kg/m2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen	Göttingen		Germany	37085

Sponsors and Collaborators

• University of Göttingen

Investigators

• Study Director: Annette Wiegand, Prof. Dr. med. dent., Dept. of Prev. Dentistry, Periodontology and Cariology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philipp Kanzow, Dr. med. dent., Dr. rer. medic., Postdoctoral Research Fellow, University of Göttingen
• ClinicalTrials.gov Identifier: NCT03516201
• Other Study ID Numbers: 28/3/17
• First Posted: May 4, 2018
• Last Update Posted: Nov 6, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Philipp Kanzow, Dr. med. dent., Dr. rer. medic., Postdoctoral Research Fellow, University of Göttingen: bariatric surgery; Periodontitis; Caries; erosive tooth wear; Gingivitis; BMI; oral health; obesity
• Additional relevant MeSH terms: Stomatognathic Diseases

Study Results

No Results Posted as of Nov 6, 2020